University declines to sanction doctor who referred patient for deadly transplant

The doctor who referred a cancer patient for the first-ever artificial trachea implant will not face disciplinary action from the University of Iceland in Reykjavik, where he works. Patient Andemariam Beyene died after the implant, a polymer scaffold seeded with his own stem cells, failed. The surgeon who developed the technique, Paolo Macchiarini, has been the center of a misconduct scandal that led to his firing from the Karolinska Institute in Stockholm and Kazan Federal University in Tatarstan, Russia. Although Macchiarini touted the success of his artificial windpipes in medical papers, all but one of the patients who received them have died. (The survivor was able to have his implant removed.)

In a 5 April statement, University of Iceland Rector Jón Atli Benediktsson said that Tómas Guðbjartsson, a thoracic surgeon at the Landspitali University Hospital in Reykjavik and a professor at the university, would not be disciplined for his role in the case, which was examined by an external ethics panel in 2017. The rector concluded that although Guðbjartsson’s conduct “is considered objectionable … the legal requirements for formal disciplinary sanctions … have not been met.” The statement says that the university also “regrets the flaws” in a 2012 symposium celebrating the first anniversary of the implant surgery.

Beyene, an Eritrean Ph.D. student in geology who was married and had three young sons, developed a tumor on his windpipe in 2009. Guðbjartsson, after concluding he had no other treatment options left, sent him to be seen by Macchiarini in Stockholm. The duo, with several other colleagues, gave Beyene an artificial windpipe in June 2011, in an operation written up in The New York Times. But the polymer trachea collapsed multiple times and caused recurring infections. Beyene died in January 2013. An autopsy found that the implant had almost completely disconnected from Beyene’s airway.

After Macchiarini’s fall, the University of Iceland and Landspítali University Hospital jointly commissioned an external ethics committee to examine the case. The committee’s report, issued in November 2017, included many damning details about Beyene’s treatment. (A summary in English is here.) Medical records show that Beyene wasn’t out of options, the panel said; his tumor, which was only 2.5 centimeters long and 1 centimeter wide—and was slow-growing—could have been treated with laser surgery. Although Beyene was originally sent to Sweden only for evaluation of his condition, within 48 hours of his arrival, Macchiarini had persuaded him to consent to the experimental surgery. Beyene was also given a suite of drugs intended to prompt the growth of stem cells. He received 10 times the recommended dose of one drug, and another that was not approved for human use. The committee concluded that Macchiarini had deceived Guðbjartsson about key aspects of the surgery—especially the fact that he didn’t have the required ethics approval—but it also said Guðbjartsson should have been more cautious about Macchiarini’s claims.

The committee is especially critical of Guðbjartsson’s role in a paper about Beyene’s case published in The Lancet in November 2011, just 5 months after Beyene’s surgery. The paper claimed that he had “an almost normal airway.” Guðbjartsson had Beyene undergo additional invasive tests to gather data for the paper, and he knew at the time that Beyene’s condition was not as good as the paper stated. (By the time the paper was published, Beyene’s implant had collapsed, and he had returned to Stockholm to have a stent inserted—a stiff tube to keep his airway open.)

Although Guðbjartsson attempted to scale back the optimistic assessment, the report says, he wasn’t able to persuade the other authors. Given that fact, he should not have agreed to be a co-author, the committee concluded. (Guðbjartsson and another doctor from Landspitali University Hospital requested in February 2017 that their names be removed from the paper, but The Lancet has not yet done so. The journal issued a “statement of concern” about the paper in April 2016 but the paper has not been retracted.)

Staff members of the University of Iceland have played a role in dragging the patient in front of the media without sufficient regard for him as a patient and student at the University of Iceland.

Report from the independent investigative committee

The committee was also critical of a 2012 symposium at the University of Iceland celebrating the first anniversary of the implant surgery. Beyene was asked to attend and speak with the media, even though just a few days earlier he had been quite ill from infections related to the implant. The panel concluded that “staff members of the University of Iceland have played a role in dragging the patient in front of the media without sufficient regard for him as a patient and student at the University of Iceland.” Guðbjartsson “should have realized that [Beyene] was in no position to refuse his requests to speak with the media,” both because he was dependent on Landspítali University Hospital for further care and because he was a student at the University of Iceland. “He was, therefore, in an extremely difficult position to refuse requests to speak with the media or release information to the media,” the report says.

Guðbjartsson declined to comment on the rector’s decision, which was first reported by German blogger Leonid Schneider. In November 2017, Guðbjartsson issued a statement saying that the decisions he had made were taken in good faith, but that he had put too much trust in Macchiarini.

The report noted that Guðbjartsson was personally close to Beyene and had done everything he could to ensure he received the best care possible following the surgery. The rector said in his statement that the critique of Guðbjartsson’s role in the saga had been made public. The case has been the subject of intense media attention in Iceland.

The university will hold an ethics workshop on 1 June, in part to summarize lessons from the affair; details on the program will be available “in a couple of weeks,” Benediktsson tells ScienceInsider.

The ethics committee report also recommended that the hospital consider compensating Beyene’s family, specifically helping his widow hire a lawyer who could help her determine whether she should bring a lawsuit regarding the case either in Iceland or in Sweden. Landspitali University Hospital is in contact with a representative for Beyene’s wife about appropriate steps to take, an official at the hospital says.